WO2005000312A8 - Particules a liberation prolongee de medicament et procede de production de celles-ci - Google Patents

Particules a liberation prolongee de medicament et procede de production de celles-ci

Info

Publication number
WO2005000312A8
WO2005000312A8 PCT/JP2004/008824 JP2004008824W WO2005000312A8 WO 2005000312 A8 WO2005000312 A8 WO 2005000312A8 JP 2004008824 W JP2004008824 W JP 2004008824W WO 2005000312 A8 WO2005000312 A8 WO 2005000312A8
Authority
WO
WIPO (PCT)
Prior art keywords
particles
theophylline
sustained
cored
release
Prior art date
Application number
PCT/JP2004/008824
Other languages
English (en)
Japanese (ja)
Other versions
WO2005000312A1 (fr
Inventor
Yuso Tomohira
Original Assignee
Otsuka Pharma Co Ltd
Yuso Tomohira
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Otsuka Pharma Co Ltd, Yuso Tomohira filed Critical Otsuka Pharma Co Ltd
Priority to EP04746293A priority Critical patent/EP1640006A4/fr
Priority to JP2005511026A priority patent/JP4592590B2/ja
Priority to MXPA05014194A priority patent/MXPA05014194A/es
Priority to US10/561,444 priority patent/US8734843B2/en
Priority to KR1020057025130A priority patent/KR101096357B1/ko
Priority to CA2529475A priority patent/CA2529475C/fr
Priority to AU2004251541A priority patent/AU2004251541B2/en
Priority to BRPI0411882-0A priority patent/BRPI0411882A/pt
Publication of WO2005000312A1 publication Critical patent/WO2005000312A1/fr
Publication of WO2005000312A8 publication Critical patent/WO2005000312A8/fr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/14—Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1617—Organic compounds, e.g. phospholipids, fats
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/519—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
    • A61K31/52—Purines, e.g. adenine
    • A61K31/522—Purines, e.g. adenine having oxo groups directly attached to the heterocyclic ring, e.g. hypoxanthine, guanine, acyclovir
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
    • A61K9/145—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
    • A61K9/146—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic macromolecular compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1641—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, poloxamers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5005—Wall or coating material
    • A61K9/501—Inorganic compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5005—Wall or coating material
    • A61K9/5021—Organic macromolecular compounds
    • A61K9/5036—Polysaccharides, e.g. gums, alginate; Cyclodextrin
    • A61K9/5042—Cellulose; Cellulose derivatives, e.g. phthalate or acetate succinate esters of hydroxypropyl methylcellulose
    • A61K9/5047—Cellulose ethers containing no ester groups, e.g. hydroxypropyl methylcellulose
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system
    • A61P11/08—Bronchodilators
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Molecular Biology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Inorganic Chemistry (AREA)
  • Biophysics (AREA)
  • Organic Chemistry (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Pulmonology (AREA)
  • Cardiology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)

Abstract

L'invention concerne des particules à libération prolongée de théophylline qui comprennent un ester d'acide gras de polyglycérol comme matrice de base, présentent une structure uniforme de particules à noyau qui permet de masquer efficacement le goût désagréable du médicament, et possèdent d'excellentes propriétés de régulation de la libération (élution) du médicament ainsi qu'une stabilité élevée au stockage. Plus spécifiquement, l'invention concerne un procédé de production de particules à libération prolongée de théophylline, caractérisé en ce qu'il comporte l'étape consistant à chauffer une matrice de base contenant un ester d'acide gras de polyglycérol, la théophylline et de l'éthyl cellulose pour former un mélange liquide ; refroidir par atomisation le mélange liquide pour former des particules sphériques à noyau qui présentent un taille moyenne de particules inférieure ou égale à 250 νm ; et enrober ensuite par fusion les particules à noyau à l'aide d'une poudre fine, etc.
PCT/JP2004/008824 2003-06-27 2004-06-17 Particules a liberation prolongee de medicament et procede de production de celles-ci WO2005000312A1 (fr)

Priority Applications (8)

Application Number Priority Date Filing Date Title
EP04746293A EP1640006A4 (fr) 2003-06-27 2004-06-17 Particules a liberation prolongee de medicament et procede de production de celles-ci
JP2005511026A JP4592590B2 (ja) 2003-06-27 2004-06-17 薬物徐放性粒子及びその製法
MXPA05014194A MXPA05014194A (es) 2003-06-27 2004-06-17 Particulas de farmaco de liberacion sostenida y procedimiento para producirla.
US10/561,444 US8734843B2 (en) 2003-06-27 2004-06-17 Medicament sustained-release particles and method for preparing the same
KR1020057025130A KR101096357B1 (ko) 2003-06-27 2004-06-17 약물 서방성 입자 및 그 제법
CA2529475A CA2529475C (fr) 2003-06-27 2004-06-17 Particules a liberation prolongee de medicament et procede de production de celles-ci
AU2004251541A AU2004251541B2 (en) 2003-06-27 2004-06-17 Sustained drug-release particles and process for producing the same
BRPI0411882-0A BRPI0411882A (pt) 2003-06-27 2004-06-17 partìculas de liberação prolongada de medicamentos e método para preparar as mesmas

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2003-184040 2003-06-27
JP2003184040 2003-06-27

Publications (2)

Publication Number Publication Date
WO2005000312A1 WO2005000312A1 (fr) 2005-01-06
WO2005000312A8 true WO2005000312A8 (fr) 2005-02-24

Family

ID=33549598

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/JP2004/008824 WO2005000312A1 (fr) 2003-06-27 2004-06-17 Particules a liberation prolongee de medicament et procede de production de celles-ci

Country Status (14)

Country Link
US (1) US8734843B2 (fr)
EP (1) EP1640006A4 (fr)
JP (1) JP4592590B2 (fr)
KR (1) KR101096357B1 (fr)
CN (2) CN1812793A (fr)
AR (1) AR045893A1 (fr)
AU (1) AU2004251541B2 (fr)
BR (1) BRPI0411882A (fr)
CA (1) CA2529475C (fr)
HK (1) HK1118484A1 (fr)
MX (1) MXPA05014194A (fr)
MY (1) MY145784A (fr)
TW (1) TW200505485A (fr)
WO (1) WO2005000312A1 (fr)

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CN101340882B (zh) * 2005-12-22 2015-02-11 大塚制药株式会社 含有药物的蜡基质粒子的制造方法、用于该方法的挤出机、及含有西洛他唑的缓释制剂
KR101697833B1 (ko) * 2005-12-22 2017-01-18 오츠카 세이야쿠 가부시키가이샤 약물 함유 왁스 매트릭스 입자의 제조 방법, 상기 방법에 사용되는 익스트루더, 및 실로스타졸을 함유하는 서방성 제제
WO2008103289A1 (fr) * 2007-02-16 2008-08-28 Elevance Renewable Sciences, Inc. Compositions de cire et leurs procédés de fabrication
US20080249178A1 (en) 2007-03-22 2008-10-09 Guosong Liu Magnesium compositions and uses thereof for increasing lifespan
US8377473B2 (en) * 2009-07-01 2013-02-19 Magceutics, Inc. Slow release magnesium composition and uses thereof
EP2540318B1 (fr) 2010-02-22 2018-10-24 Daiichi Sankyo Company, Limited Préparation solide à libération prolongée pour utilisation orale
WO2011102505A1 (fr) * 2010-02-22 2011-08-25 第一三共株式会社 Préparation solide à libération prolongée pour usage oral
EP2893928B1 (fr) 2012-09-03 2018-10-24 Daiichi Sankyo Company, Limited Composition pharmaceutique à libération prolongée administrée par voie orale contenant du chlorhydrate d'hydromorphone
CN107050023A (zh) * 2017-01-13 2017-08-18 北京顺慈医药科技有限公司 一种盐酸小檗碱的制剂及遮盖药物不良味道的制剂方法
CA3086820A1 (fr) 2017-12-28 2019-07-04 Sumitomo Dainippon Pharma Co., Ltd. Nouveau revetement de microparticules (particules creuses comprenant un medicament et procede de fabrication de celles-ci)
JP7294143B2 (ja) 2018-01-05 2023-06-20 凸版印刷株式会社 複合粒子および乾燥粉体
CN112313289A (zh) * 2018-04-27 2021-02-02 凸版印刷株式会社 缓释性复合颗粒、缓释性复合颗粒的制造方法、干燥粉体、以及壁纸
CN108904451A (zh) * 2018-07-27 2018-11-30 广州柏赛罗药业有限公司 缓释制剂
JP6618595B1 (ja) * 2018-10-16 2019-12-11 佐藤薬品工業株式会社 カフェインおよびヒヨスチアミン含有医薬組成物およびその製造方法
EP3870229A1 (fr) * 2018-10-22 2021-09-01 IOI Oleo GmbH Additif pour une poudre destinée à être pressée pour former des pièces moulées
CN114209887B (zh) * 2021-08-24 2023-03-03 杭州协合医疗用品有限公司 一种含可控降解聚酯微球的注射用凝胶
CN113877000B (zh) * 2021-10-13 2023-01-24 科笛生物医药(无锡)有限公司 注射用微球组合物及其应用

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Also Published As

Publication number Publication date
CA2529475A1 (fr) 2005-01-06
CA2529475C (fr) 2012-08-07
JP4592590B2 (ja) 2010-12-01
MY145784A (en) 2012-04-30
KR20060026071A (ko) 2006-03-22
TWI333858B (fr) 2010-12-01
BRPI0411882A (pt) 2006-08-29
US8734843B2 (en) 2014-05-27
AU2004251541A1 (en) 2005-01-06
CN101219115B (zh) 2012-09-19
TW200505485A (en) 2005-02-16
JPWO2005000312A1 (ja) 2006-08-03
EP1640006A1 (fr) 2006-03-29
KR101096357B1 (ko) 2011-12-20
WO2005000312A1 (fr) 2005-01-06
CN1812793A (zh) 2006-08-02
US20070098843A1 (en) 2007-05-03
AR045893A1 (es) 2005-11-16
CN101219115A (zh) 2008-07-16
EP1640006A4 (fr) 2012-04-04
HK1118484A1 (en) 2009-02-13
AU2004251541B2 (en) 2010-03-04
MXPA05014194A (es) 2006-02-24

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